Issued byNational Institutes of Health (NIH)
Centers for Disease Control and Prevention (CDC)

Purpose

Innovative technologies and methodologies fuel progress in biomedical and behavioral research and represent an increasingly important area of the economy. The Small Business Innovation Research (SBIR) program provides support for research and development (R&D) of new or improved technologies and methodologies that have the potential to succeed as commercial products.

The purpose of this notice is to (1) announce the issuance of the Solicitation of the National Institutes of Health and the Centers for Disease Control and Prevention for Small Business Innovation Research Contract Proposals (PHS 2013-1) with a receipt date of November 13, 2012; and (2) inform the public about the opportunities that the SBIR program offers to small business concerns as well as to scientists at research institutions.

The SBIR legislation requires the Public Health Service (PHS), Department of Health and Human Services, and certain other Federal agencies to reserve 2.6 percent (for FY2012) of their extramural research or R&D budgets for an SBIR program. (The NIH SBIR set-aside requirement for FY 2012 is $632 million.)

The offeror organization must be a small business concern as defined by the Small Business Administration and described in the Contract Solicitation. The primary employment of the principal investigator MUST be with the small business concern at the time of award and during the conduct of the proposed project. In accord with the intent of the SBIR program to increase private sector commercialization of innovations derived from Federal R&D, scientists at research institutions can play an important role in an SBIR project by serving as consultants and/or subcontractors to the small business concern. Generally, up to 1/3 of the Phase I budget may be spent on consultant and/or subcontractual costs, and, generally, up to 1/2 of the Phase II budget may be spent on such costs. In this manner, a small business concern with limited expertise and/or research facilities may benefit from teaming with a scientist(s) at a research institution; for the scientist(s) at a research institution, this team effort provides support for R&D not otherwise obtained. The SBIR program consists of the following three phases:

PHASE I: The objective of this phase is to determine the scientific and technical merit and feasibility and potential for commercialization of the proposed research or R&D efforts and the quality of performance of the small business concern, before consideration of further Federal support in Phase II. Generally, Phase I SBIR awards do not exceed $150,000 for direct costs, Facilities and Administrative (F&A) costs, and negotiated fixed fee for a period generally not to exceed six months.

PHASE II: The objective of this phase is to continue the research or R&D efforts initiated in Phase I. Funding shall be based on the results of Phase I and the scientific and technical merit and commercial potential of the Phase II proposal. Phase I contractors are eligible to apply for Phase II grant or contract funding and will be informed of Phase II opportunities. (However, see "Fast-Track" Initiative below.) Generally, Phase II awards do not exceed $1,000,000 for direct costs, F&A costs, and negotiated fixed fee for a period generally not to exceed two years.

PHASE III: The objective of this phase is for the small business concern to pursue, with non-SBIR funds, the commercialization of the results of the research or R&D funded in Phases I and II.

"FAST-TRACK" INITIATIVE: (Applicable only to proposals submitted to the NIH and only if an awarding component indicates that it is accepting Fast-Track proposals for a particular topic.)

The Fast-Track initiative is an opportunity for small business concerns to submit both a Phase I and Phase II proposal for concurrent peer review. This initiative also has the potential to minimize any funding gap between Phase I and Phase II. Proposals must be prepared in accordance with Phase I and Phase II proposal preparation instructions.

Following are the research topics contained in the PHS 2013-1 Solicitation:

National Institute on Drug Abuse (NIDA)
147 A Mobile Application to Help Patients Take their Pill Medications as Prescribed: Improving Medication Adherence
148 Products for at-home Deactivation of Psychoactive Prescription Medicines
149 Development of Predictive in vivo Screening Systems for Phenotypic Drug Discovery for Smoking Cessation
150 Video Game Targeting Relapse Prevention in Youth with Substance Use Disorders

National Center for Emerging Zoonotic and Infectious Diseases (NCEZID)
003 Development of Nanoparticle Dengue Diagnostic Tests
004 Development of Tests in a Standardized Kit Format for Diagnosis of Arboviral Infections in Resource-Limited, Primary Health Care Setting
005 Reducing Antimicrobial Resistance through Improved use of Laboratory Testing Information in Healthcare Facilities

National Center for HIV/AIDs, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)
034 Development of Biomedical Devices to Elicit Durable Protective Immunity against HIV
035 Development of a Portable Multiplex Assay for Determination of Recent HIV-1 Infection
036 Testing the Efficacy of Combination HIV Prevention Strategies in Nonhuman Primates

National Center for Immunization and Respiratory Diseases (NCIRD)
025 Development of an Inactivated Rotavirus Vaccine for Use in Global Immunization
026 Thermostable Dry Measles Vaccine Formulation for Sublingual Administration

Office of Public Health Preparedness and Response (OPHPR)
002 Improved Methods for Collection, Preservation, and Transportation of Biological Specimens

Note: The SBIR Phase I Contract Solicitation is available ONLY via electronic means. Potential offerors are encouraged to check the NIH Small Business Research Funding Opportunities Web site for updates on the program. Any updates or corrections to the Solicitation will be posted there.

Contracting Officers

Any small business concern that intends to submit an SBIR contract proposal under this Solicitation should provide the appropriate contracting officer(s) with early, written notice of its intent, giving its name, address, e-mail, telephone, and topic number(s). If a topic is modified or canceled before the Solicitation closes, only those companies that have expressed such intent will be notified.